The Association of CPAP Compliance Study
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|ClinicalTrials.gov Identifier: NCT02796846|
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : July 8, 2019
|Condition or disease|
|Obstructive Sleep Apnea|
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder. CPAP is established to be the first line treatment for OSA patients with improvement in quality of life and significant reduction in the incidence of cardiovascular events. However, the evidence on the efficacy of CPAP in the perioperative period is largely lacking. A prospective cohort study conducted by Brar et al. found that despite the use of prescibed CPAP therapy, 18% of OSA patients became hypoxic on the night following surgery and they advocated postoperative oximetry monitoring in CPAP treated OSA surgical patients.
The investigators would like to determine the effect of CPAP compliance in reducing postoperative hypoxia and other complications in the surgical patients with OSA. The results from this study would provide valuable data on the rate of non-compliance to CPAP in the surgical patients with a history of diagnosed OSA and a CPAP prescription and the impact of non-compliance to CPAP on postoperative outcomes, especially oxygen saturation.
In this study, all diagnosed OSA surgical patients with or without a CPAP prescription will be approached for informed consent to enroll in the study. All study participants will be monitored for O2 desaturation by using wrist-watch pulse oximeter at home for one night preoperatively and first 3 nights post-operatively at the hospital.
The subjects enrolled will bring their own CPAP units (certified by the hospital engineering department as per hospital policy) and mask to the hospital. The OSA patients without a CPAP prescription will be followed up perioperatively to determine the severity of their OSA and to ascertain the rationale of no CPAP prescription.
Pre and post-operative CPAP usage data will be collected through interviewing the patient, chart review and monitoring recording in the smart CPAP device.
|Study Type :||Observational|
|Actual Enrollment :||158 participants|
|Official Title:||The Association of CPAP Compliance and Nocturnal Hypoxemia in the Perioperative Period|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 2019|
CPAP prescription group
Patients with a CPAP prescription (both compliant and noncompliant)
Without a CPAP prescription
Patients without a CPAP prescription to satisfy our primary goals/objectives.
- CPAP compliance [ Time Frame: (average CPAP use ≥ 4hrs / night). ]CPAP compliance (average CPAP use ≥ 4hrs / night)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796846
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|